Clinical Comfort Evaluation of Two Marketed Spherical Contact Lenses

NCT02356692 | Completed Results FDA Device

• 1 other identifier: EX-MKTG-38-MTF
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this study was to investigate the overall clinical comfort performance of enfilcon A (test) lens and senofilcon A (control) lens over 15-minutes of lens wear.

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (4)

• Comfort at Insertion

  Participant's response for comfort at insertion. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at baseline.

  Baseline

• Comfort at Insertion

  Participant's response for comfort at 15 minutes. (Scale 0-10; 0=poor/intolerable, 10=comfortable/ cannot be felt) Obtained at 15 minutes.

  15 minutes

• Comfort Preference

  Participant's response for comfort preference of enfilcon A (test) lens, senofilcon A(control) lens at insertion.

  Baseline

• Comfort Preference

  Participant's response for comfort of enfilcon A (test) lens, senofilcon A (control) lens at 15 minutes wear.

  15 minutes

Study Arms (2)

enfilcon A

EXPERIMENTAL

participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.

Device: enfilcon A; Device: senofilcon A

senofilcon A

ACTIVE COMPARATOR

participants randomized to wear the Enfilcon A (test) lens in one eye and Senofilcon A (control) lens in the other eye.

Device: enfilcon A; Device: senofilcon A

Interventions

enfilcon A DEVICE

Test lens

enfilcon A; senofilcon A

senofilcon A DEVICE

Control lens

enfilcon A; senofilcon A

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Based on his/her knowledge, must be in good general health.
• Be 18 to 38 years old.
• Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
• Read, indicate understanding of, and sign Written Informed Consent.
• Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses (Avaira or Oasys) being evaluated in this trial.
• Require a visual correction in both eyes.
• Require a prescription between +8.00D and -12.00D and have less than or equal to 0.75D of astigmatism in both eyes.
• Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
• No amblyopia.
• No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
• lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection).
• No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology).
• No aphakia.

You may not qualify if:

• D or greater of refractive astigmatism in either eye.
• Presbyopic or current monovision contact lens wear.
• Cannot be currently wearing either lenses (Avaira or Oasys).
• Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammation such as iritis; or any infection of the eye, lids, or associated structures.
• Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
• Slit lamp findings that would contraindicate contact lens wear such as:
• Pathological dry eye or associated findings
• Pterygium, pinguecula or corneal scars within the visual axis
• Neovascularization \> 0.75 mm in from the limbus
• Giant papillary conjunctivitis (GPC) worse than Grade 1
• Anterior uveitis or iritis (past or present)
• Seborrheic eczema, seborrheic conjunctivitis
• History of corneal ulcer or fungal infections
• Poor personal hygiene
• A known history of corneal hypoesthesia (reduced corneal sensitivity)

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (3)

Schaeffer Eye Associates

Birmingham, Alabama, 35216, United States

Location

Beaches Family Eyecare

Jacksonville, Florida, 32256, United States

Location

Todays Eyecare, LLC

Lafayette, Louisiana, 70503, United States

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Donald Siegel, OD
• Organization: CooperVision

dsiegel@coopervision.com

602 485 3414

Study Officials

• Donald Siegel, OD

  CooperVision, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: February 5, 2015
• Study Start: April 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 23, 2020
• Results First Posted: November 23, 2020

Record last verified: 2020-10

Locations

US (3)